Clinical Trial: Rejuvenated RBC and VO2 Max in Healthy Subjects

U.S., March 28 -- ClinicalTrials.gov registry received information related to the study (NCT03089047) titled 'Rejuvenated RBC and VO2 Max in Healthy Subjects' on March 20.
Brief Summary: To compare the physiologic benefits of rejuvenated RBCs (rejRBCs) to standards RBCs (PRBCs), the investigator will emulate critical conditions by safely maximizing stress on the cardiovascular system, in an elective, feasible volunteer study. VO2max will be measured in an anemic, post-donation, pre-transfusion state, and also after transfusing 18-day-old, autologous blood randomized to standard storage or standard storage with rejuvenation. The investigator hypothesizes that transfusion of standard PRBCs is less effective at increasing oxygen delivery (measured by VO2max) compared with transfusion of rejRBCs
Study Start Date:
Study Type: Interventional
Condition: Erythrocyte Transfusion
Intervention: Biological: Transfusion of rejuvenated and washed autolgous RBCs
Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol(R), Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol(R) is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations.
Biological: Transfusion of washed autolgous RBCs
Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm
Recruitment Status: Not yet recruiting
Sponsor: Duke University
Information provided by (Responsible Party): Duke University